KZIAホームページ引用
SYDNEY, Dec. 31, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today provided a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA).
In July 2024, the Company reported topline results from the GBM-AGILE study in which newly diagnosed unmethylated (NDU) patients with glioblastoma treated with paxalisib showed a clinically meaningful improvement in a prespecified secondary analysis for overall survival (OS) compared to standard of care. Based on these results and the totality of data from all completed paxalisib clinical studies, Kazia requested a meeting with the FDA to discuss potential clinical and regulatory paths forward.
Following discussions with the FDA and feedback from Kazia's recent Type C meeting, the FDA's current position is that data on OS would generally not be appropriate for accelerated approval, but could be considered to support a traditional/standard approval. The Agency further commented that the secondary endpoint OS data from the GBM-AGILE study are supportive and informative for designing and executing a pivotal registrational study in pursuit of a standard approval. Importantly, the Company aligned with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study, including patient population, primary endpoint, and the comparator arm to be used.
→
FDAは、、
accelerated approvalには不十分だから、、、
a traditional/standard approvalを目指しましょうね、、。そのための、三相治験のデザインをと。
(むむ、時間も、お金もかかりますね。KZIA単独では無理でしょうね。)
だから、、、
→
The Kazia team, in conjunction with the Board of Directors, is continuing to evaluate several options, and we expect to provide an outline for our path forward to maximize shareholder value by the end of January 2025."
とりあえず月末までに道筋をつけると？相方？または、嫁ぎ先か？
(わたしは、素人である。私のポストに投資アドバイスは含まれない。素人の雑感にすぎない。バイオは、恐ろしくリスキーだ。素人にとっては、ただのギャンブルである。そこを承知すべきである。)
KZIAホームページ引用
SYDNEY, Dec. 31, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today provided a regulatory update on paxalisib for the treatment of glioblastoma (GBM) following its Type C clinical meeting with the United States Food and Drug Administration (FDA).
In July 2024, the Company reported topline results from the GBM-AGILE study in which newly diagnosed unmethylated (NDU) patients with glioblastoma treated with paxalisib showed a clinically meaningful improvement in a prespecified secondary analysis for overall survival (OS) compared to standard of care. Based on these results and the totality of data from all completed paxalisib clinical studies, Kazia requested a meeting with the FDA to discuss potential clinical and regulatory paths forward.
Following discussions with the FDA and feedback from Kazia's recent Type C meeting, the FDA's current position is that data on OS would generally not be appropriate for accelerated approval, but could be considered to support a traditional/standard approval. The Agency further commented that the secondary endpoint OS data from the GBM-AGILE study are supportive and informative for designing and executing a pivotal registrational study in pursuit of a standard approval. Importantly, the Company aligned with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study, including patient population, primary endpoint, and the comparator arm to be used.
→
FDAは、、
accelerated approvalには不十分だから、、、
a traditional/standard approvalを目指しましょうね、、。そのための、三相治験のデザインをと。
(むむ、時間も、お金もかかりますね。KZIA単独では無理でしょうね。)
だから、、、
→
The Kazia team, in conjunction with the Board of Directors, is continuing to evaluate several options, and we expect to provide an outline for our path forward to maximize shareholder value by the end of January 2025."
とりあえず月末までに道筋をつけると？相方？または、嫁ぎ先か？
(わたしは、素人である。私のポストに投資アドバイスは含まれない。素人の雑感にすぎない。バイオは、恐ろしくリスキーだ。素人にとっては、ただのギャンブルである。そこを承知すべきである。)
投資の参考になりましたか？